Implantable urinary control apparatus

ABSTRACT

An implantable urinary control apparatus for controlling the flow of urine from the bladder including a pump adapted to be connected to the bladder for pumping urine out of the bladder and into a natural or artificial channel so that it can be from the fromthe body. The apparatus also includes a sensor adapted to be connected to the natural or to an artificial urinary bladder for detecting the pressure in the bladder as it fills with urine, and an alarm unit connected to the sensor for giving warning that the bladder is filling with urine when the sensor detects the pressure caused by urine in the bladder.

United States Patent [191 Summers [111 3,810,259 [451 May 14,1974

[ IMPLANTABLE URINARY CONTROL APPARATUS [75] Inventor: George D.Summers, Bethesda, Md.

[73] Assignee: Fairchild Industries, Inc.,

Germantown, Md.

[22] Filed: Apr. 6, 1973 [21] Appl. No.: 348,644

Related U.S. Application Data [60] Continuation of Ser. No. 109,308,Jan. 25, 197 1, abandoned, which is a division of Ser. No. 842,921,

July 18, 1969, Pat. No..3,575,158.

[52] U.S. Cl. 3/1, l28/DIG. 25 [51] Int. Cl. A611 1/24 [58] Field ofSearch 3/1, 1.1, DIG. 2; 128/1 R,

128/13, 1.5, 214 R, 273, 419 E, DIG. 25;

OTHER PUBLICATIONS A New Minature Pump for Treatment of Hydrocephalus"by G. D. Summers et al., Journal of the Association for the Advancementof Medical Instrumentation,

-Vol. 2, N0. 3, May/June 1967, pages 9-16.

[ 5 7] ABSTRACT An implantable urinary control apparatus for controllingthe flow of urine from the bladder including a pump adapted to beconnected to the bladder for pumping urine out of the bladder and into anatural or artificial channel so that it can be from thefromthe body.The apparatus also includes a sensor adapted to be connected to thenatural or man artificial urinary bladder for detecting the pressure inthe bladder as it fills with urine, and an alarm unit connected to thesensor for giving warning that the bladder is filling with urine whenthe sensor detects the pressure caused by urine in the bladder.

7 Claims, 3 Drawing Figures P T N Efi nAY 14 m4 FIIG.I

INVENTOR GEORGE D SUMMERS ATTORNEY.,.

l IMPLANTABLE URINARY CONTROL APPARATUS This application is acontinuation of application, Ser. No. 109,308, filed Jan. 25, 1971, nowabandoned, which in turn is a division of application Ser. No. 842,921,filed July 18, 1969, now U.S. Pat No. 3,575,158.

This invention relates to an implantable control apparatus, moreparticularly, this invention relates to an implantable control apparatusfor controlling the discharge of urine from the urinary bladder.

The failure to discharge urine from the bladder can cause urine to backup into the kidneys and this can result in serious medical consequencessuch as uremia and infections. Present techniques for medicallyrelieving the failure of urine to flow from the urinary bladder throughthe urethra and to'outside the body depend in part on the cause offailure. In some cases the bladder wall no longer functions either fromfailure of the motor nerve pathways leading to the bladder, fromdeterioration of the bladder wall or muscle, or from a neoplastic growthinterfering with normal function.- In such cases, the usual medicaltreatment is to insert a catheter through the urethra and into thebladder. Flow is then controlled by opening or closing a portion of thecatheter external to the body. This process leads to infection of theurethra and/or the urinary bladder in most patients when the catheter isleft in place for more than a few days. Often this infection isdifficult to control or cure with antibiotics, especially when thecatheter remains in the body. Additionally, uric acid crystals and othermatter may form or collect in the catheter, leading to restricting orstopping fluid flow.

Another cause of failure of urine flow is the inability of the patientto voluntarily cause the sphincters (constricting muscles) around theurethra to relax. Again in this case a catheter may be used. A morerecent technique has been tried which consists of an implantedelectrical stimulator attached to the sphincters or their afferentnerves. Powered and controlled in one of several ways, the electricalcurrent supplied can cause sphincter relaxation. However, the system hasnot always proved useful over a period of time as the sphincters requireincreasingly large values of current and/or voltage. Finally a point maybe reached when either pain or burn will occur beforesphincterrelaxation.

In cases of urinary incontinence in which there is continuous orintermittent involuntary voiding of urine, present management techniquesinclude wearing of absorbent diaper-like clothing and the collection ofurine in watertight bags. Unfortunately, these techniques areinconvenient to use and can cause considerable discomfort to thepatient.

Reference is made to the device described in my copending applicationSer. No. 814,760 filed Apr. 9, 1969, now U.S. Pat. No. 3,672,352, whichdescribes the use of implantable sensors for detecting body conditionsin connection with implantable signal means and means for transmittingenergy into the body and receiving signals from inside the body.

It is therefore an object of the present invention to provide animplantable urinary control apparatus for controlling the discharge ofurine from the urinary bladder.

Another object of this invention is to provide an implantable urinarycontrol apparatus that is capable of detecting the pressure in theurinary bladder caused by the filling of the bladder with urine.

Another object of the present invention is to provide an implantableurinary control apparatus that is capa-:

ble of giving a warning when the bladder is filling with urine.

Another object of the present invention is to provide an implantableurinary control apparatus having a pump that is capable of being poweredand controlled from outside the body. The present invention provides animplantable urinary control apparatus for controlling the discharge ofurine from the urinary bladder in a body which includes implantable pumpmeans for pumping urine from the bladder out of the body, implantableinlet means connected to the implantable pump means for connecting thebladder to the implantable pump means for permitting urine to flow fromthe bladder to the implantable pump means and implantable outlet meansconnected to the implantable pump means for connecting the implantablepump means to an artificial or natural body channel that leads out ofthe body for permitting urine to flow from the implantable pump means tothe artificial or natural body channel. Means capable of beingoperatively coupled to the pump means for operating the pump means,implantable sensing and alarm means, and a power source for the alarmmeans are also provided.

In order that the invention may be more clearly set forth and betterunderstood, reference is made to the accompanying drawings in which:

FIG. 1 is a diagramatic view showing typically how the invention wouldbe implanted within the body of a human;

FIG. 2 is a diagramatic view of an alternative embodiment of theinvention implanted within the body of a human; and

FIG. 3 is a circuit diagram of the alarm unit, battery and chargingcircuit used in the preferred embodiment of the invention.

Referring first to FIG. 1, there is shown a bladder 10 connected to thekidneys 11. The bladder 10 may be the natural urinary bladder or animplanted artificial urinary bladder and any reference to the wordbladder in the specification and claims is meant to include both naturalor artificial urinary bladders, except where an artificial bladder isspecified as an element in the claims. Connected to the bladder 10 isthe urethra and- /or artificial urethra 12 that is surrounded by thesphincters 13 which are muscles that are normally closed so that urinecannotflow out of the bladder through the urethra. In the normal bodythese sphincters 13 are opened or closed by voluntary controlled nerveimpulses. It should be understood that any reference to the word urethrain the specification and claims is meant to include both the natural orartificial urethra or other suitable natural or artificial channel ortube that leads outside the body. An implanted tube 14 is connected tothe bladder 10 and to the inlet of an implanted pump 15 to permitpassage of urine from the bladder to the pump. An implanted tube 16 isconnected to the outlet of the pump 15 and to the urethra 12 below thesphincters 13 to permit the passage of urine from the pump to theurethra when the pump is activated. An implanted pump driving unit 17that is responsive to energy received from outside the body is operablyconnected to the pump 15 and is controlled and powered by an externalpump activating unit 18 that transmits energy from outside the bodythrough the skin and into the body to the pump driving unit to drive thepump.

A pressure sensor 19 is connected to the implanted tube 14 and detectspressure in the bladder when it fills with urine. An implanted alarmunit 20 is connected to the pressure sensor 19 by means of an implantedelectrical connection 21 that transmits a signal to activate the alarmunit when the bladder is full of urine. A rechargeable implanted powersource 22 is connected to the implanted alarm unit 20 for supplyingpower to the alarm unit. An implanted recharging unit 23 is connected tothe power source 22 to permit recharging of the power source. Theimplanted recharging unit 23 is energized by means of an external energytransmitter 24 that transmits energy from outside the body through theskin and into the body to the recharging unit. This energy causes therecharging unit 23 to recharge the power source 22.

In the preferred embodiment of the invention the pump 15, the pumpdriving unit 17, and the external pump activating unit 18 are similar inconstruction to the magnetically driven pump and accessories describedin an article entitled A New Miniature Pump for the Treatment ofHydrocephalus by Summers and Matthews in the May/June 1967 issue of TheJournal of the Association for' the advancement of MedicalInstrumentation and to the device described in my copending applicationSer. No. -74I,l17 filed June 27, 1968, now U.S. Pat. No. 3,527,220. Inthe preferred embodiment the implanted pump driving unit 17 consists ofa suitable rotatable magnet operably connected to the pump so that therotation of the magnet will cause the pump to operate. In the preferredembodiment the external pump activating unit 18 that is used to controland operate the pump 15 by transmitting energy into the body consists ofa motor 25 that is operably connected to a rotatable magnet 26. When themotor 25 is turned on, this causes rotation of the magnet 26. Therotation of the magnet 26 causes the implanted magnet in the drivingunit 17 to rotate due to the action of the magnetic field between theexternal magnet and the implanted magnet within the driving unit 17. Therotation of the magnet within the pump driving unit 17 causes the pump15 to operate and pump urine from the bladder 10 through the implantedtube 14, through the pump, and through the implanted tube 16 into theurethra 12 at a point below the sphincters 13.

Other types of pumps can be employed; however, a magnetically drivenpump is highly desirable since once it has been implanted, it can bepowered from outside the body without having to penetrate the skin. Analternative type of pump that could be employed would be driven byimplanted batteries that could be recharged by the action of a rotatingmagentic field located outside the body. Activation of this alternativetype of pump could be achieved by a suitable electromagnetic signal fromoutside the body.

In the preferred embodiment of this invention the external energytransmitter 24 consists ofa motor 27 that is operably connected to arotatable magnet 28. When the motor 27 is turned on, this causes themagnet 28 to rotate which results in the generation of a moving magneticfield within the implanted recharging unit 23 that causes the rechargingunit to recharge the power source 22. Through the proper selection ofcircuitry it is possible that the pump activating unit 18 can also serveas the external energy transmitter 24. Alternatively, the implantedrecharging unit 23 can be energized by means of an energy transmitter 24that includes an rf generator.

In FIG. 2 an alternative embodiment of the invention is shown in whichthe implanted pressure sensor 19 is connected to an implantedrestraining band 29 that partially or totally surrounds the urinarybladder 10. This pressure sensor 19 is pressed against the wall of theurinary bladder 10 as the bladder increases in size as a result of itsbeing filled with urine. When the pressure sensor 19 detects pressureresulting from the distention of the urinary bladder 10 as it is filledwith urine, the sensor energizes the implanted alarm unit 20 throughimplanted electrical connection 21 as previously described with respectto the embodiment shown in FIG. 1.

FIG. 3 illustrates a circuit diagram of the preferred embodiment of theimplanted alarm unit 20, the implanted power source 22 and the implantedrecharging unit 23. The alarm unit includes a resistive heating element30 and a switch 31 that is closed by a signal from the sensor 19 whenthe sensor detects pressure resulting from the filling of the bladderwith urine. When the switch 31 is closed, the resistive heating element30 becomes heated by the action of the electrical current generated bythe battery 32 in the power source 22. The resistive heating element 30must become hot enough to be sensed by the patient, but not hot enoughto cause damage to the tissue surrounding the implanted resistor. Theswitch 31 opens and the heat sensation that results from the resistiveheating element 30 is relieved when the implanted pump 15 is activatedand urine is pumped out of the bladder 10 since the pressure sensor 19no longer detects pressure in the bladder and thus is not transmitting asignal to keep the switch 31 in its closed position.

A test switch 33 that is normally open is connected in parallel with theswitch 31 to permit testing of the alarm unit. This test switch 33 canbe of a type that is magnetically activated so that it can be closed bya suitable means such as a magnetic source (not shown) located outsideof the body. The battery 32 should be rechargeable and recharging isaccomplished by means of the implanted recharging unit 23 and theexternal energy transmitter 24. In the preferred embodiment therecharging unit 23 has an induction coil 34 that is connected inparallel with the battery 32 and a diode 35 that is connected in serieswith the induction coil. The recharging unit is energized from outsidethe body by the energy transmitter 24 which in the preferred embodimenthas a motor 27 that is used to drive a rotatable magnet 28. A current isgenerated in the induction coil by means ofa moving magnetic field byplacing the rotating magnet 28 at a point outside the body that is closeto the induction coil in the implanted recharging unit 23. The accurrent that is generated in the induction coil 34 by this movingmagnetic field is rectified by the diode 35 and the rectified currentcharges the battery 32. The diode 35 also serves the purpose ofpreventing the battery 32 from discharging through the coil 34.Alternatively, a mechanical vibrator, an optical source that is visiblethrough the skin, an rf source or an externally interrogated telemetryunit can be employed as the alarm unit 20.

The alarm unit 20, the power source 22, the recharging unit 23 and thepump 15 including the driving unit 117 must be covered by a suitableinner layer such as standard latex rubber over a suitable case toprotect these implanted devices. This inner layer must then be coated bya suitable outer layer of material that is compatible with body tissue.Various types of silicone rubber compositions are suitable for thisouter layer. Some examples of these suitable compositions are presentedin U.S. Pat. No. 3,279,996. These protective layers also protect thebody by electrically insulating these devices from the body. In asimilar manner, the electrical connection 21 and the pressure sensor 19must be covered by a suitable insulating material and by a material suchas silicone rubber that is compatible with body tissue. In addition thetubes 14 and 16 must consist of some material that will not permitdiffusion of urine through their walls and the outside of the tubes mustbe coated with silicone rubber or some other such material that will becompatible with the body tissue.

In some cases it will not be necessary to employ an implanted alarm unit20 and associated devices. In this situation the implanted alarm unit20, the implanted power source 22, the implanted recharging unit 23, theimplanted pressure sensor 19 and the implanted electrical connection 21can be omitted. In this situation it will also be unnecessary to utilizeany sort of external energy transmitter 24.

To utilize this invention the pump 15 including the connected pumpdriving unit 17, the alarm unit 20, the rechargeable power source 22,and the recharging unit 23 are implanted into the body so that they arelocated close to the skin. Appropriate anchoring devices such as wingsor tabs of a silicone net-like material can be attached to these devicesto maintain them in their desired locations within the body. Body tissuewill grow through this net-like material and thus anchor the implanteddevices within the body. The inlet of the pump 15 must also be connectedto the bladder preferably by implanting the tube 14 and connecting it tothe bladder and the pump inlet. The outlet of the pump must also beconnected to a natural or artificial channel 12 that leads out'of thebody at a point below the sphincters 13 preferably by implanting thetube 16 and connecting it to the pump outlet and the channel.Alternativelyv the pump outlet can be connected to some other suitablenatural or artificial channel thatcan be used to discharge urine fromthe body. In some cases where the patient suffers urinary incontinence,in which there is involuntary voiding of urine, it may be desirable toclose the urethra 12 surgically at some point above where the tube 16connects to the urethra.

The pressure sensor 19 is also implanted into the body and operablyconnected to the bladder 10 for detecting the pressure in the bladder asit fills with urine. If it is desired to practice the embodiment of theinvention shown in FIG. 1, then the pressure sensor 19 is implanted andoperably connected to the bladder 10 by connecting it to the implantedtube 14 thatis connected to the bladder. If it is desired to practicethe embodiment of the invention shown in FIG. 2 then the restrainingband 29 that can partially or completely surround the bladder isimplanted into the body around the bladder and the pressure sensor 19 isimplanted and connected to the restraining band. The implanted pressuresensor 19 is also connected to the alarm unit 20 necting it to thepressure sensor and the alarm unit.

After the urinary control apparatus has been implanted within the body,the filling of the bladder 10 with urine will activate the pressuresensor 19 which, in turn, will activate the alarm unit 20. In thepreferred embodiment activation of the alarm unit will cause theresistive heating element 30 to generate heat that will be sensed by thepatient. When the patient feels this heat, he will know that his bladderis full and should be emptied. The patient can accomplish the emptyingof his bladder by activating the pump 15 by means of the implanted pumpdriving unit 17 and the external pump activating unit 18. If the motor25 and the magnet 26 are employed. the patient places the magnet overthe implanted pump driving unit 17 and starts the motor. The resultingmoving magnetic field causes the implanted magnet in the driving unit 17to rotate and this activates the pump 15 to pump urine from the bladder10 and out of the body. As soon as the patient has pumped sufficienturine from his bladder 10, the pressure sensor 19 will no longer detectpressure in the bladder and this will result in deactivation of thealarm unit 20 and stop the resistive heating element 30 from generatingheat.

In the event that the patient is unable to sense the heat from theresistive heating element 30 or to use the external rotatable magnet 26and motor 25 himself, a suitable heat sensor (not shown) can be taped onthe outside of his skin near the implanted alarm unit 20 so that it willdetect the heat generated by the resistive heating element 30 when thebladder 10 is full of urine. This heat sensor can be connected to asuitable external signalling system to call for assistance in pumpingout the bladder. The battery 32 in the power source 22 can beperiodically recharged by use of the external energy transmitter 24which can consist ofa motor 27 and a rotatable magnet 28. To rechargethe battery 32 with this device the patient places the magnet 28 overthe coil 34 in the recharging unit 23 and activates the motor tomagnetically induce an electric current in the coil that will rechargethe battery. The patient may also test the alarm unit by activating thetest switch 33 which in the preferred embodiment will simulate theclosing of the switch 31 by a signal from the pressure sensor 19 andresult in current flowing in the resistive heating element 30. Thus thepatient should feel heat after the switch is closed if the alarm unit isoperating properly and the battery is charged.

In the event that the patient should develop an infection in his bladderand it should be desirable to irrigate the'bladder, this can beaccomplished through the use of this implanted urinary control apparatusby merely causing the pump 15 to operate in reverse to pump a suitableirrigating solution from outside the body into the bladder 10. When theimplanted urinary apparatus is used for this purpose, the pressuresensor 19 and the alarm unit 20 can serve the purpose of warming thepatient when the bladder 10 is full of the irrigating solution so thatthe solution will not be forced up into the kidneys and of preventingundue distention of the bladder. The pump can also be operated inreverse to cleanse the implanted apparatus by pumping a suitablesolution through the apparatus from outside the body in the event theapparatus becomes clogged with uric acid crystals or other matter.

In some cases such as when it is planned to pump urine from the bladder10 at preset time intervals by means of the pump 15 and the associateddevices that have been previously described, it will be unnecessary toutilize the alarm unit 20. In such cases it will be unnecessary toimplant the alarm unit 20. the power source 22, the recharging unit 23,the electrical connection 21, the pressure sensor 19, and any associatedrestraining band 29. In these cases it is also unnecessary to use anyexternal energy transmitter 24. When the alarm system 20 is notimplanted and utilized, the pump must be activated according to someschedule to insure that the bladder 10 does not fill with urine to theextent that it would bring undesirable results.

This invention has been previously described primarily in relation toits use within the body of a human, however, it can also be implantedwithin the body of an animal to control the animals urinary functions.

Although the invention has been described in considerable detail withreference to certain preferred embodiments, it will be understood thatvariations and modifications may be made within the spirit and scope ofthe invention as defined in the appended claims.

What is claimed is: 1. An implantable urinary control apparatus forcontrolling the discharge of urine from the urinary bladder in a bodycomprising implantable pump means for pumping urine from said urinarybladder out of the body, implantable inlet means connected to saidimplantable pump means for connecting said urinary bladder to saidimplantable pump means for permitting urine t0 flow from said bladder tosaid implantable pump means, implantable outlet means connected to saidimplantable pump means for connecting said implantable pump means to anartificial or natural body channel that leads out of the body to permiturine to flow from said implantable pump means to said artifcial ornatural body channel, means capable of being operatively coupled to saidimplantable pump means for causing the operation thereof, implantablesensing means adapted to be operatively associated with said bladder forsensing pressure in said bladder as said bladder is filling with urine,implantable alarm means operatively connected to said implantablesensing means for providing an alarm when said sensing means sensespressure in said bladder as said bladder is filling with urine, andimplantable power source means operatively connected to said alarm meansfor supplying power to said implantable alarm means.

2. The implantable urinary control apparatus of claim 1 wherein saidalarm means comprises a resistive heating element.

3. The implantable urinary control apparatus of claim 1 wherein saidsensing means is connected to said implantable inlet means.

4. The implantable urinary control apparatus of claim 1 furthercomprising implantable recharging means operatively connected to saidimplantable power source means and means locatable outside the body fortransmitting energy into the body to cause said implantable rechargingmeans to recharge said implantable power source means.

5. The implantable urinary control apparatus of claim 1 furthercomprising securing means connected to said sensing means for securingsaid sensing means to said urinary bladder.

6. The implantable urinary control apparatus of claim 5 wherein saidsecuring means comprises a strap.

7. An implantable urinary control apparatus for controlling thedischarge of urine from a body comprising an artificial implantableurinary bladder, implantable pump means for pumping urine from saidimplantable bladder out of the body, implantable inlet means connectedto said implantable pump means and to said implantable bladder forpermitting urine to flow from said implantable bladder to saidimplantable pump means, implantable outlet means connected to saidimplantable pump means for connecting said implantable pump means to anartificial or natural body channel that leads out of the body forpermitting urine to flow from said implantable pump means to saidartificial or natural body channel, and means capable of beingoperatively coupled to said pump means for operating said implantablepump means.

1. An implantable urinary control apparatus for controlling thedischarge of urine from the urinary bladder in a body comprisingimplantable pump means for pumping urine from said urinary bladder outof the body, implantable inlet means connected to said implantable pumpmeans for connecting said urinary bladder to said implantable pump meansfor permitting urine to flow from said bladder to said implantable pumpmeans, implantable outlet means connected to said imPlantable pump meansfor connecting said implantable pump means to an artificial or naturalbody channel that leads out of the body to permit urine to flow fromsaid implantable pump means to said artificial or natural body channel,means capable of being operatively coupled to said implantable pumpmeans for causing the operation thereof, implantable sensing meansadapted to be operatively associated with said bladder for sensingpressure in said bladder as said bladder is filling with urine,implantable alarm means operatively connected to said implantablesensing means for providing an alarm when said sensing means sensespressure in said bladder as said bladder is filling with urine, andimplantable power source means operatively connected to said alarm meansfor supplying power to said implantable alarm means.
 2. The implantableurinary control apparatus of claim 1 wherein said alarm means comprisesa resistive heating element.
 3. The implantable urinary controlapparatus of claim 1 wherein said sensing means is connected to saidimplantable inlet means.
 4. The implantable urinary control apparatus ofclaim 1 further comprising implantable recharging means operativelyconnected to said implantable power source means and means locatableoutside the body for transmitting energy into the body to cause saidimplantable recharging means to recharge said implantable power sourcemeans.
 5. The implantable urinary control apparatus of claim 1 furthercomprising securing means connected to said sensing means for securingsaid sensing means to said urinary bladder.
 6. The implantable urinarycontrol apparatus of claim 5 wherein said securing means comprises astrap.
 7. An implantable urinary control apparatus for controlling thedischarge of urine from a body comprising an artificial implantableurinary bladder, implantable pump means for pumping urine from saidimplantable bladder out of the body, implantable inlet means connectedto said implantable pump means and to said implantable bladder forpermitting urine to flow from said implantable bladder to saidimplantable pump means, implantable outlet means connected to saidimplantable pump means for connecting said implantable pump means to anartificial or natural body channel that leads out of the body forpermitting urine to flow from said implantable pump means to saidartificial or natural body channel, and means capable of beingoperatively coupled to said pump means for operating said implantablepump means.